RecruitingNCT06229717

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)

Sponsor

Gødstrup Hospital

Enrollment

48 participants

Start Date

Aug 20, 2025

Study Type

OBSERVATIONAL

Conditions

Sensorineural Hearing Loss Children, Only Vestibular Disorder Vestibular Function

Summary

The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires and vestibular and postural assessments.

Eligibility

Min Age: 3 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cervical Vestibular Evoked Myogenic Potential, Computerized Dynamic Posturography, and others for people with children, only, sensorineural hearing loss, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Years to 10 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTvideo Head Impulse Test

For v-HIT, the Synapsys v-HIT Ulmer device is used.

DIAGNOSTIC_TESTCervical Vestibular Evoked Myogenic Potential

For cVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.

DIAGNOSTIC_TESTOcular Vestibular Evoked Myogenic Potential

For oVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.

DIAGNOSTIC_TESTComputerized Dynamic Posturography

To evaluate functional balance of the children and the relative contributions of the vision, proprioception, and vestibular system a CDP from Virtualis (Virtualis, Montpellier, France) is used.

OTHERDizziness Handicap Inventory for patient caregivers

DHI is a caregiver-reported 21- item questionnaire. It is designed to evaluate the perceived quality of life and handicap resulting from dizziness and unsteadiness for the pediatric population. For each question there are three possible answers: yes, sometimes or no. Each answer provides respectively 4, 2 and 0 points. The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap. Scores under 16 are characterized as no limitation or handicap. A score from 16-26 present a mild perceived handicap and mild limitations. A DHI-score between 26-43 is classified as a moderate problem, and a score above 43 describes a severe perceived handicap and severe limitations.